Evidence map›Paper›PMID 26666258›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2016

Placebo-controlled study in neuromyelitis optica-Ethical and design considerations.

Bruce Ac Cree, Jeffrey L Bennett, Mark Sheehan, Jeffrey Cohen, Hans-Peter Hartung, Orhan Aktas, Ho Jin Kim, Friedemann Paul, Sean Pittock, Brian Weinshenker and 9 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02200770 (A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02200770 phase2 / phase3completednot on this map

A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

TypeinterventionalSponsorMedImmune LLCRan2015 to 2020Enrolled231ConditionsNeuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersArmsInebilizumab, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 71 citations in OpenAlex.

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  17. Thymus-derived B cell clones persist in the circulation after thymectomy in myasthenia gravis.Proceedings of the National Academy of Sciences of the United States of America · 2020
    Article
  18. Review
  19. Neuromyelitis optica spectrum disorders with unevenly clustered attack occurrence.Neurology(R) neuroimmunology & neuroinflammation · 2020
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 10 institutions in 5 countries.

Bruce Ac CreeMultiple Sclerosis Center, Department of Neurology, University of California San Francisco, San Francisco, CA, USA bruce.cree@ucsf.edu.
Jeffrey L BennettProgram in Neuroscience, Departments of Neurology and Ophthalmology, University of Colorado, Denver, CO, USA.
Mark SheehanThe Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Jeffrey CohenCleveland Clinic, Cleveland, OH, USA.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Berlin, Germany.
Orhan AktasDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Berlin, Germany.
Ho Jin KimResearch Institute and Hospital of National Cancer Center, Goyang, South Korea.
Friedemann PaulCharite-University Medicine Berlin, Berlin, Germany.
Sean PittockMayo Clinic, Rochester, MN, USA.
Brian WeinshenkerMayo Clinic, Rochester, MN, USA.
Dean WingerchukMayo Clinic, Scottsdale, AZ, USA.
Kazuo FujiharaTohoku University, Sendai, Japan.
Gary CutterThe University of Alabama at Birmingham, Birmingham, AL, USA.
Kaushik PatraMedImmune, Gaithersburg, MD, USA.
Armando FlorMedImmune, Gaithersburg, MD, USA.
Gerard BarronMedImmune, Cambridge, UK.
Soraya MadaniMedImmune, Gaithersburg, MD, USA.
John N RatchfordMedImmune, Gaithersburg, MD, USA.
Eliezer KatzMedImmune, Gaithersburg, MD, USA.
Mayo Clinic in Arizona · USHeinrich Heine University Düsseldorf · DECharité - Universitätsmedizin Berlin · DECleveland Clinic · USNational Cancer Center · KRTohoku University · JPUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Oxford · GB

Funding

Humoral Immunity, Astrocyte Injury, and Demyelination in Neuromyelitis OpticaR01EY022936 · NEI · UNIVERSITY OF COLORADO DENVER · PI BENNETT, JEFFREY L · 2013 to 2022
$3.8M
NEI NIH HHS R01 EY022936
6 · The paper itself

Abstract

backgroundTo date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no controlled clinical studies have been reported.

objectiveTo design a placebo-controlled study in NMO that appropriately balances patient safety and clinical-scientific integrity.

methodsWe assessed the "standard of care" for NMO to establish the ethical framework for a placebo-controlled trial. We implemented measures that balance the need for scientific robustness while mitigating the risks associated with a placebo-controlled study. The medical or scientific community, patient organizations, and regulatory authorities were engaged early in discussions on this placebo-controlled study, and their input contributed to the final study design.

resultsThe N-MOmentum study (NCT02200770) is a clinical trial that randomizes NMO patients to receive MEDI-551, a monoclonal antibody that depletes CD19+ B-cells, or placebo. The study design has received regulatory, ethical, clinical, and patient approval in over 100 clinical sites in more than 20 countries worldwide.

conclusionThe approach we took in the design of the N-MOmentum trial might serve as a roadmap for other rare severe diseases when there is no proven therapy and no established clinical development path.

Indexed as

Ethics, ResearchResearch DesignAntibodies, Monoclonal, HumanizedHumansImmunologic FactorsNeuromyelitis OpticaTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedImmunologic Factorsinebilizumabanti-CD19 monoclonal antibodyethicsMEDI-551Neuromyelitis opticatrial design

Identifiers

PMID26666258
PMCPMC4904355
OpenAlexW2345500349

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.